New Colony Counting Software and Validation Procedures from Synbiosis Offer Antimicrobial Manufacturers a Faster Route to GMP Compliance
02 Apr 2008Synbiosis, a world-leading manufacturer of automated microbiological systems, is delighted to announce the availability of new ProtoCOL software for automatic colony and inhibition zone analysis, as well as full validation information for its entire range of automated colony counters. The combined use of software and validation protocols will provide a vital link in the quality chain, ensuring antibiotic or vaccine efficacy results generated from these instruments support GMP (Good Manufacturing Practice).
The new ProtoCOL software, integral to Synbiosis’ automated ProtoCOL colony counters and AutoZone zone sizing systems, has been extensively upgraded so that both image and written data generated by the software can be integrated into a 21 Code of Federal Regulations (CFR), Part 11 environment. Additionally, Synbiosis’ market leading ProtoCOL, AutoZone and åCOLyte systems, which have always been Good Laboratory Practice (GLP) compliant, now come with clear, detailed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) procedures, making on-site validation of these systems in a clinical testing environment, a quick and easy task.
Martin Smith of Synbiosis commented: “With the global increase in development of vaccines and antibiotics, our colony counting and inhibition zone measuring systems are becoming a gold standard in many pharmaceutical production facilities. To meet the regulatory demands GMP compliance requires, our technical team has spent thousands of hours developing excellent software for secure data storage, as well as writing full validation methods for our systems. This means microbiologists in pharma and biotech companies can now rapidly install and begin using a ProtoCOL or AutoZone as part of their clinical quality assurance, confident that the data package generated on their novel anti-microbial therapies is suitable for presentation to the FDA or other regulatory authorities.”